Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imaging Services, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010772 | ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM | Imaging Services, Inc. | 2001-08-23 | 162 | 0 |
| K955251 | OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM | Imaging Services, Inc. | 1996-04-12 | 149 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda